Nasal cavity dilator device

ABSTRACT

An improved adjustable nasal dilator device ( 1 ) insertable within the nasal cavity of a human being to improve the flow of air through the nasal passage. The device includes a body ( 2 ) comprising a top ( 3 ) and bottom ( 4 ) frame ends interconnected by a series of spaced flexible ribs ( 5 ). The top and bottom frame ends are open and substantially circular, and the diameter of the bottom frame end is greater than the corresponding diameter of the top frame end to provide a body shape for convenient insertion within a nasal cavity.

This application is a continuation-in part of U.S. patent applicationSer. No. 11/363,884, filed on Feb. 28, 2006 and Australian PatentApplication Ser. No. 2007202425, filed on May 28, 2007.

FIELD OF THE INVENTION

The present invention relates to an improved nasal cavity device for usein the nasal cavity of a human being to aid passage of air through thenasal cavity. More particularly the present invention relates to animproved adjustable nasal cavity device for combined passage of air anda medicament or fragrance and the like.

BACKGROUND OF THE INVENTION

Snoring and general breathing dysfunctions are common ailments thataffect a significant proportion of the world's population. People whoare disposed to such conditions can be subject to feelings of generaltiredness, shortness of breath, fatigue, sleep deprivation, snoring, andeven sleep apnea, which can increase the risks of cardiac arrest.

Attempts have been made to address the above conditions. For instanceone option available to sufferers involves a surgical procedure. Apartfrom requiring a sufferer to endure invasive surgery and the relativelyhigh costs associated therewith, it is documented that surgicalprocedures are often temporarily successful, sufferers requiringrepeated surgery to obtain ongoing relief.

Other methods of addressing snoring, related breathing difficulties andthe like have included nasal sprays. One problem with sprayformulations, however, is that they often contain steroidal orvasoconstrictor active agents that cause side effects and can lead to achronic addiction problem or withdrawal difficulties. A further problemwith spray formulations is that frequent dosing is required.

Alternatives to surgical procedures and sprays have included a range ofcontraptions that can be worn like a mask on the face of a sufferer tohelp maintain airways in an open condition. These types of devicesinvolve complex designs that are very conspicuous on a wearer. Othertypes of devices that are worn externally include a resilient plasterapplied over the bridge of the nose to externally expand the nostrils. Aproblem associated with this type of approach is that the plaster is notaesthetically pleasing, and is limited by both the inherent resiliencyof the plaster and its ability to exert a sufficient outward force toexpand and maintain a nostril cavity in an open condition. In additionthe plaster requires painful removal that could result in the tearing ofskin.

Other devices are disclosed in patent documents such as a devicedescribed in U.S. Pat. No. 5,895,409 that can be inserted within thenasal cavity. This device has a rigid structure and requiresmanufacturers to make different sized devices to cater for a range ofcavity sizes. Also problems frequently arise in a nasal application whena wearer exhibits a deviated septum. A deviated septum is a curvature inthe septum, the cartilage and bone that separates the nostrils. A curvedseptum often renders one nasal cavity a different shape and size to itsneighbour and inhibits airflow through one side of the nose and canresult in airflow blockage through one nostril. Prior art devices, ofthe type disclosed in U.S. Pat. No. 5,895,409 that are insertable withinthe nasal cavity, suffer the drawback that if one dilator of asymmetrical pair, to be inserted, is of a sufficiently small size toenter one nostril then the remaining dilator of the pair is too small tobe effective in dilating the other nostril. Conversely, if one device ofa symmetrical pair is sufficiently large to effectively dilate onenostril, its pair is often too large to be inserted in the othernostril. Even further, the device of U.S. Pat. No. 5,895,409 cannot beused to deliver a medicament.

A similar device is disclosed in U.S. Pat. No. 3,710,799, whichdescribes a pair of open cages joined together by a flexible chain ofinter-locked links, the cages being slightly larger than the nostrilsbut insertable therein so that the nose holds the cages in place. Thisdevice confers a deal of discomfort for a wearer upon insertion becausethe device is generally larger than the corresponding orifice in whichit is to be inserted. Other devices are available that include aresilient plastic strip with widened ends. This type of device isusually bent prior to insertion to conform to a U-shape with the wideends being inserted into the nostrils. The extent of dilation of thenostril cavity depends on the resiliency of the plastic to return to itsnormal configuration. These type of dilators are very uncomfortable fora wearer and the force generated by the resilient plastic often causesirritation to the inside lining of the nose not to mention that thearticle is conspicuous.

More recently the present applicant has developed a nasal cavitydilation device that addresses some of the aforementioned problems. Theapplicant's own U.S. Pat. No. 7,105,008 describes an adjustable nasalcavity device for improving flow of air through the nasal passage of awearer.

To date no device or system has been provided which is capable ofcombining improved flow of air and delivering a medicament or fragranceor like material. This is likely because of the size constraints withinthe nasal cavity of a human. Hence, further improvement is required toaddress this problem.

Even further, general breathing problems can be initiated upon exposureto dusts, pollens, and pollution. Many people are predisposed toallergies, hay fever and even asthma on exposure to such environmentaltriggers. To date various means of minimising exposure to such triggershas included wearing of masks. Wearing of masks however is unsightly andsignificantly restricts flow of air into the nasal cavity.

It should be understood that any reference to prior art does notconstitute an admission of common general knowledge.

Hence it is an object of the present invention to provide a device,which addresses one or more of the prior art disadvantages. A furtherobject is to provide a means to help improve flow of air through thenasal passage of a human. A further object is to provide a means ofcombining flow of air with a supply of a medicament or fragrance or thelike into the nasal passage of a human. An even further object is toprovide a filter means which does not substantially restrict the flow ofair into a human nasal cavity.

SUMMARY OF THE INVENTION

In accordance with the invention there is provided a nasal cavity devicefor combined flow of air through the nasal passage and a medicament orfragrance and the like, the device including:

a body for insertion within a human nasal cavity, the body being capableof deforming to exert an effective force on internal surfaces of a nasalcavity and thereby improve air flow through the nasal passage;

an expansion means for mounting the body, wherein in an operatingcondition the expansion means urges against the body causing the body todeform;

at least one defined air flow pathway within the device;

a releasable locking means for locking the expansion means and the bodyin operable engagement;

a demountable fragrance/medicament holder mounted in a portion of theexpansion means wherein the fragrance holder and expansion means definea fragrance/medicament channel accessible to the air flow pathway;

wherein air entering the fragrance channel dispenses fragrance ormedicament or the like from the fragrance/medicament holder into the airflow pathway.

The device in accordance with the present invention allows release of amedicament or fragrance by interaction with an air stream passingthrough the at least one defined airflow pathway. Medicament released bythe passage of air can be absorbed into the body for a desiredtherapeutic effect.

The present device represents an improvement over the prior art devicesbecause it provides a means of combining enhanced airflow through anasal passage of a human patient with a fragrance or medicament. Thefragrance/medicament holder can also be replaced or replenished to allowrepeated dispensing of a fragrance or medicament of the like.

The fragrance channel can have an air inlet and air outlet to allow airflow through the channel for fragrance dispensing whereby fragrancemerges with the at least one defined air flow pathways within thedevice.

The fragrance holder can be mounted in a central portion of theexpansion means to maximize airflow and fragrance dispensing.

The fragrance holder can include a central holding means withinterrupted well structures to allow lateral egress of fragrance ormedicament or the like and an annular mounting means with air cavitiestherebetween to allow mounting while allowing longitudinal ingress ofair flow past the central holding means.

The expansion means can include a central housing structure comprisinginterrupted wall members ending in a centrally located platform, whichextends into the body of the device. In an assembled condition thecentral holding means of the fragrance holder can be received within thecentral housing structure, wherein the platform rests on the interruptedwell structures thereby forming a roof for the central holding means.

The releasable interlocking means can include a male and female matingelements. In one embodiment the male element is mounted to the roof andextends into the body, and the female element is a oppositely disposedtubular sleeve structure extending within the body and wherein the maleelement is releasably received within the female element tosubstantially maintain the body in a desired deformed position to exertan effective force on internal surfaces of the nasal cavity walls.

One advantage of the present invention is that the central platform ofthe expansion means forms a roof enclosure for the central holding meansof the fragrance holder and provides a support or mounting surface forthe male element of the interlocking system.

The body can comprise a top frame end forming a collar and a bottomframe end forming a waistband wherein the top and bottom frame ends areinterconnected by a deformable wall structure. The deformable wallstructure is preferably formed from a series of spaced apart ribmembers. In an assembled condition the expansion means is mounted on thebottom frame end. In an operating condition the expansion means is urgedby an external force against the bottom frame end causing displacementof the bottom frame end towards the top frame end whereby the flexiblewall structure deforms laterally of the body to exert a force againstinternal surfaces of a nasal cavity wall.

Preferably the releasable interlocking means can include:

an upstanding member extending from the central platform of theexpansion means, wherein when the expansion means is mounted on thebottom frame end the upstanding member is centrally located of the body,and wherein at least a part of the upstanding member includes a seriesof circumferential teeth;

a tubular sleeve member extending downwardly from the top frame end forreceiving the upstanding member, at least a part of the sleeve includingcomplementary internal teeth adapted to engage with the circumferentialteeth; and

wherein the upstanding member is received within the sleeve member uponapplication of an external force to one or both of the frame ends andthereafter the top and bottom frame ends are maintained at a desireddistance and allowing suitable lateral deformation of the flexible ribsto exert an effective force on surfaces of the nasal cavity walls toimprove passage of air therethrough.

In a related aspect of the present invention there is disclosed a nasalcavity device for combined flow of air through the nasal passage and amedicament or fragrance and the like, the device including:

a body for insertion within a human nasal cavity, the body being capableof deforming to exert an effective force on internal surfaces of a nasalcavity and thereby improve air flow through the nasal passage;

an expansion means for mounting the body, wherein in an operatingcondition the expansion means urges against the body causing the body todeform, the expansion means including a central housing structurecomprising interrupted wall members ending in a centrally locatedplatform which extends into the body of the device;

at least one defined air flow pathway within the device;

a releasable locking means for locking the expansion means and the bodyin operable engagement;

a demountable fragrance/medicament holder including central holdingmeans comprising interrupted well structures to allow lateral egress offragrance or medicament or the like and an annular mounting means withcavities therebetween to allow mounting to the expansion means whileallowing longitudinal ingress of air flow past the central holdingmeans,

wherein in an assembled condition the central holding means of thefragrance holder is received within the central housing structure suchthat the platform rests on the interrupted well structures to form aroof for the central holding means thereby defining a fragrance ormedicament channel for merging with the air flow pathway.

The expansion means can include a base ring structure having an innercircumferential shoulder for supporting the bottom frame end thereon andan outer concentric circumferential platform for supporting an externalsheath/cage for protecting the body.

The expansion means can include a central housing comprising interruptedwall members such as a series of spaced apart legs interconnected to acentral platform wherein the legs extend substantially upwardly withinthe body from or adjacent to edge portions of the inner circumferentialshoulder. Preferably the spaced legs end in shoulder portions which eachconnect directly to the central platform. Preferably the edge portionsinclude an opening therein to receive portions of a bridge structure.

The fragrance holder preferably includes a ring-like base structurebeing interconnected to a centrally located housing structure whereinairflow cavities are located therebetween. The centrally located housingis preferably comprised of spaced wall sections adapted to be receivedwithin the central housing of the expansion means. The fragrance holdercan also include a u-shaped recess within the ring-like base structureto accommodate an arm portion of a bridge member.

The releasable locking means can comprise of interlocking components onthe top frame end and the expansion means, the interlocking componentsbeing adjustably interlockable for maintaining the top and bottom frameends of the body at a distance effective for the wall structure to exerta desired dilating force for improving passage of air through the nasalcavity.

Preferably the releasable interlocking means can include:

an upstanding member extending from the central platform of theexpansion means, wherein when the expansion means is mounted on thebottom frame the upstanding member is centrally located of the body, andwherein at least a part of the upstanding member includes a series ofcircumferential teeth;

a tubular sleeve member extending downwardly from the top frame end forreceiving the upstanding member, at least a part of the sleeve includingcomplementary internal teeth adapted to engage with the circumferentialteeth; and

wherein the upstanding member is received within the sleeve member uponapplication of an external force to one or both of the frame ends andthereafter the top and bottom frame ends are maintained at a desireddistance and allowing suitable lateral deformation of the flexible ribsto exert an effective force on surfaces of the nasal cavity walls toimprove passage of air therethrough.

Preferably the device can include an outer sheath adapted to mount overthe body. The sheath comprises a circumferential bottom frame end, whichin use is supported on the outer circumferential platform of theexpansion means, and spaced apart ribs extending upwardly from thecircumferential bottom frame end ending in curved fingers for grippingattachment at the top frame end of the body.

In one embodiment of the present invention the device can be joined to asecond device by means of a bridge member whereby each device can beadjusted independently or cojointly. The bridge member includes agenerally symmetric u-shaped transparent structure ending in adjustableelements. In use the adjustable elements of the bridge member arereceived through an opening provided in edge portions of the expansionmeans wherein the adjustable elements allow fine adjustment of theposition of the bridge member. The fragrance holder preferably providesa recess in the base ring structure so that when the fragrance holder ismounted to the expansion means the recess accommodates a portion of thebridge member.

In a related aspect of the present invention there is disclosed a methodof delivering a medicament to the nasal cavity of a human beingincluding:

providing a device having:

a body having a top frame end forming a collar and bottom frame endforming a waistband, the top and bottom frame ends being interconnectedby a series of spaced apart flexible ribs, wherein the ribs deformlaterally of the body with a change in distance between the frame ends,

an expansion means including a base ring structure having at least aninner circumferential shoulder for mounting to the waistband, wherein inan operating condition the circumferential shoulder urges against thewaistband to initiate displacement of the waistband relative to thecollar, the expansion means further including a central mounting portionformed of interrupted wall members ending in a central platform;

at least one air flow pathway within the device;

a releasable interlocking means for locking the expansion means and thebody in adjustable operating engagement;

a fragrance holder including mounting means for mounting on theexpansion means, wherein the fragrance holder includes a central holderfor mounting within the central mounting portion of the expansion meanssuch that the central platform forms a roof for the central holder andwherein the fragrance holder and the expansion means define a fragrancechannel accessible to the air flow pathway;

the method including inserting the device within a nasal cavity of ahuman, manipulating the expansion means so that it is urged against thewaistband, wherein the flexible ribs expand laterally against innersurfaces of a nasal cavity wall to allow substantially improved air flowthrough the nasal passage.

The body can be adjusted in situ or externally of the nasal cavity by awearer to tailor a desirable degree of lateral expansion against innersurfaces of the nasal cavity walls. Hence air flow can be improved bysuitable adjustment of the device by the wearer until the wall structureexerts a selectable desired dilating force against surfaces of the nasalcavity walls. Unlike any prior art device the instant device enablescontrolled adjustability. Even further, the device provides an airflowpathway, which is accessible to a fragrance or medicament channel toinitiate dispensing of a fragrance or medicament so that it merges withthe airflow pathway.

In a related aspect of the present invention there is disclosed a nasalcavity device for combined flow of air through the nasal passage andfiltering air, the device including:

a body for insertion within a human nasal cavity, the body being capableof deforming to exert an effective force on internal surfaces of a nasalcavity and thereby improve air flow through the nasal passage;

an expansion means for mounting the body, wherein in an operatingcondition the expansion means urges against the body causing the body todeform;

at least one defined air flow pathway within the device;

a releasable locking means for locking the expansion means and the bodyin operable engagement;

a demountable filter holder mounted to a portion of the expansion meanswherein the filter holder receives a filter member in a seatedarrangement adjacent the nasal cavity opening,

whereby air entering the at least one defined pathway passes through thefilter member and wherein deformation of the body is sufficient to exertan effective opening force on the nasal cavity walls to substantiallyminimize airflow restriction.

Generally it is accepted that an air filter device worn by a human willhave the effect of reducing exposure to environmental allergy triggersbut at the same time reduce the flow of air. The present device providesa means of expanding the nasal cavity to allow improved airflow throughthe nasal passage of a human. Without being bound by any theory, thenasal cavity expansion provided by the present device substantiallyminimizes airflow resistance otherwise posed by the filter member.

The filter holder can include a circular base and arcuate mount portionsadapted to engage receiving portions within the expansion means. Thefilter member can include a substantially circular pad, the diameter ofwhich is sized to abut wall surfaces of the nasal cavity. The filterholder can further include radial arms and a semi-circular recess forreceiving at least a portion of a bridging member.

In a related aspect of the present invention there is disclosed acontrollably adjustable nasal cavity dilation device including:

a body having a top and bottom frame ends interconnected by a flexiblewall structure, the body being shaped to enable insertion of the devicewithin the cavity, wherein the flexible wall structure has a geometrywhich changes with a change in distance between the top and bottom frameends as; and

a releasable holding means adapted to maintain the top and bottom frameends at a desired distance when in a holding condition such that thegeometry of the wall structure is effective to substantially increaseair flow through the nasal passage,

wherein when the holding means is in a non-holding condition thedistance between the top and bottom frame ends are adjustable byapplication or release of an external force to the body therebyproducing a change in the geometry of the flexible wall structure.

The geometry of the flexible wall structure preferably describes asubstantially arcuate pathway, the extent of curvature beingproportional to the distance between the top and bottom frame ends,wherein the holding means retains the wall structure in a desiredarcuate geometry in the holding condition and enables re-positioning ofthe wall structure by further application or release of the force whenthe holding means is released from the holding condition.

The wall structure of the device can be a series of spaced apartelongate rib members. The series of ribs each describe an arcuatepathway from the top frame end to the bottom frame end. This accentuatesthe disposition of the walls/ribs to extend outwardly when therespective ends of the body of the device are subjected to a compressiveforce exerted by the expansion means. Alternatively the flexible wallstructure can be formed by a series of slits in an otherwise continuousstructure.

The releasable holding means can include a locking system which assiststo maintain the relative positions of the top and bottom frame ends suchthat the flexible wall structure is retained in an adjustably desiredgeometry for improving passage of air through the nasal cavity. Anadvantage of the holding means is that the geometry of the device can bemaintained in an adjusted configuration to enable improved airflow thatsuits a wearer's individual requirements. Hence the amount ofadjustability of the device can be controlled by the wearer.

The holding means in one such lockable form can be irreversible such asknown on security ties or be unlockable. A substantial benefit in thereversible locking of the holding means is its use in changing thedimensions of the structure when the user has a different condition andthe nasal cavity size has changed or where a user over-expands thedevice prior to insertion; the holding means allows for further fineadjustment. Such a condition can occur due to inflamed sinuses orbecause of colds, influenza and other nose affecting ailments or due tophysical damage such as sunburnt noses, broken or damaged noses.Although it also allows use by different users this is an unlikely eventfor hygiene reasons.

The holding means can be a setting means where a material piece is ableto hold a selected position by its nature or after being treated such asheat treated in that position. This can include metallic means, whichhave a degree of flexibility but retain the position after being flexed.Another means is heat settable plastics such that after selection of thecorrect size the item is set by insertion in hot water or otherwise.

The locking system can consist of interlocking components on the top andbottom frame ends, the interlocking components being adjustablyinterlockable for maintaining the frame ends at a distance effective forthe wall structure to exert a desired dilating force for improvingpassage of air through the nasal cavity.

The interlockable components can include:

a holding base frame mountable on the bottom frame end, the base framehaving an upstanding member centrally located of the flexible wallstructure when the base frame is mounted on the bottom frame, wherein atleast a part of the upstanding member includes a series ofcircumferential teeth;

a tubular sleeve member extending downwardly from the top frame end forreceiving the upstanding member, at least a part of the sleeve includingcomplementary internal teeth adapted to engage with the circumferentialteeth,

wherein the upstanding member is received within the sleeve member uponapplication of an external force to one or both of the frame ends andthereafter the top and bottom frame ends are maintained at a desireddistance and allowing sizing of the flexible wall to exert a dilationforce on the nasal cavity walls.

The external force applied to the device to cause expansion of theflexible wall structure can be a rotational force or a linear force tourge displacement of the top and/or bottom frame ends away from ortowards each other.

The holding base structure can include a suspension platforminterconnected thereto for housing a medicament such as menthol whereinthe suspension platform extends within the body of the device so thatthe medicament is suspended out of direct surface contact with wallsurfaces of the nasal cavity.

The device can comprise two bodies for simultaneous insertion withinadjacent nasal cavities, the bodies being interconnected by a linkingmember to form a symmetrical or asymmetrical pair.

The linking member is able to interconnect the two bodies by attachmentto the holding base structures or by joining the flexible wallstructures of the two bodies. An advantage of the dual system is thatthe two bodies can be independently and controllably adjusted to suitrespective nasal cavities since a wearer may want to dilate one of thepair. The linking member can join the two structures together for easeof use and as a safety measure to avoid over insertion. The link meansalso acts as a safety mechanism to prevent accidental inhalation. In afurther variation the link means can also act as the compression means.

The nasal cavity dilation device can further including a compressionmeans engaging with the flexible wall structure wherein when the holdingmeans is in a non-holding condition, application or release of a forceon the compression means causes the flexible wall structure to movelaterally with respect to the body to describe an arcuate pathway. Thedevice can be adjusted by applying a force to the compression means toprovide a choice of one of a plurality of second dilated geometries suchthat the user can select an appropriate size relative to the user'snasal cavity and the holding means can maintain the selected size.

The top and bottom frame ends of the device can be substantiallycircular or elliptical in cross-section having openings therein, suchthat the top frame end has a smaller circumferential opening than thebottom frame end.

The bottom frame end can include an angled surface to suit the anglebetween the septum and adjacent wall of a nostril cavity to besubstantially hidden from an observers view. The advantage of having anangled bottom end enables the device to be better hidden from anobservers view.

In a further related aspect of the present invention there is discloseda nasal dilation device for improving air flow through a nasal cavityincluding:

a first deformable body; the first deformable body having an uppermostsubstantially circular open end forming a collar and a lowermostsubstantially circular open end forming a waistband;

a series of spaced ribs connecting between the uppermost and lowermostends, the body including a central member mounted on the collar andextending longitudinally within the body towards the lowermost end;

a holding base having a central leg mounted thereon, which leg is ableto extend into the first deformable body with the holding base engagingthe waistband of the first deformable body;

the leg of the holding base and the central member of the firstdeformable body having complementary engagement means allowingengagement which causes the holding base to act against the waistband inresponse to an external force so that the ribs are deflected outwardlyof the body to a desired size for dilating the nasal cavity.

The first deformable body is preferably hollow and the leg of theholding base includes a series of spaced apart circumferentialprotrusions of external diameter equal to or greater than the internaldiameter of the hollow central member.

The ribs are extendable in a direction outwardly relative to the body asthe leg of the holding base progressively enters the hollow member forallowing the extent of desired dilation of a nasal cavity to becontrolled.

The holding base can include a central platform on which the leg ismounted and extends upwardly towards the central member. The holdingbase can further include a locking ring interconnected to the platformby a series of radial arms, the locking ring including an annularshoulder that abuts the waistband when the leg engages within thecentral member.

The central member of the first deformable body is preferably hollow andcontains a series of internal teeth and wherein the leg of the holdingbase can include a series of mating teeth adapted to releasably engagewith said internal teeth of the central member. Alternatively thecentral member of the first deformable body is preferably hollow andcontains an internal screw thread that mates with an external threadedsection on the leg of the holding.

The holding base can also include a recessed protrusion for receiving avapor delivery system. The advantage of the delivery of medicated vapourby the present device is that any substance such as ‘Vapor Rub’ can beheld away from contact with the skin while allowing inhalation ofmedicated vapour. Hence the substance is able to function purely as avapour for inhalation while substantially eliminating irritation thatcan otherwise be caused by direct contact with the skin.

The device can further include a filter. The filter can reduce theamount of airborne irritants that can otherwise infiltrate the bronchialsystem and cause an allergic reaction. While the filter may cause somerestriction in the flow of air, any restriction is offset by theexpansion of a nostril as a result of the dilation device. The device ofthe invention is suited to any size nostril, is economic, reusable andaesthetically pleasing.

The nasal dilation device can further include a second deformable bodyinterconnected to the first deformable body by a bridge, wherein thefirst and second deformable bodies are preferably substantiallysymmetrical about a longitudinal axis extending centrally of the bridge.

In yet a further related aspect of the present invention there isdescribed a nasal dilation device for improving air flow through a nasalcavity including:

a first adjustable body and a second adjustable body interconnected by abridge, the first and second body being substantially symmetrical abouta longitudinal axis extending centrally of the bridge;

each of the first and second bodies having an uppermost end forming acollar and a lowermost end forming a waistband greater in diameter thanthe collar, the uppermost end and lowermost ends being interconnected bya series of spaced resilient ribs, each body further including a hollowcylindrical member extending along a longitudinal axis of each bodytowards the lowermost end;

the device further including a releasable holding member for each bodyhaving a base member and a central leg which is able to extend into thehollow cylindrical member, the leg including a series of spaced apartcircumferential protrusions of external diameter equal to or greaterthan the internal diameter of the hollow cylindrical member allowing theleg to enter the hollow cylinder so that the protrusions engage thehollow cylinder and the base member engages the internal sides of thewaistband or the ribs extending from the collar so that the ribs aredeflected outwardly of the body to dilate the cavity to a desired size.

In still a further related aspect of the present invention there isdescribed an adjustable nasal dilation device including:

a first deformable body having one or more ribs able to engage opposinginternal sides of a nasal cavity wall when in position; and

an adjustable holding member which expands the first deformable body toenlarge the nasal cavity.

The adjustable holding member can comprise two arm members whichinterengage from opposing sides of the first deformable body.

The adjustable nasal cavity dilation device can further include:

a second deformable body connected to the first deformable body by asubstantially U-shaped bridge to form an uppermost portion and alowermost portion, the lowermost portion being sufficiently wide to spana nasal septum; the uppermost portion ending in a rib member extendingdownwardly at an angle to the first and second deformable bodiesrespectively, the first and second deformable bodies being symmetricalabout a longitudinal axis extending centrally of the lowermost portion;

each of the rib members having mounted thereto a first arm memberextending inwardly, each arm member including a series of ridgesseparated by valleys;

the first and second deformable bodies each having mounted thereon asecond resilient arm member extending oppositely the first arm membertowards the rib members, which second resilient arm members include arecess proximal to each end for engaging with a valley between adjacentspaced ridges on a first arm member so that the angle between the ribmembers and the first and second deformable body is reversibly adjustedby urging the ridges over the recess.

The first and second deformable bodies can further include a third armmember mounted thereon extending outwardly towards respective ribmembers, each of the third arm members being disposed above the secondopposing arm members, each of the third arm members having a protrusionextending below the level of each arm, which protrusion acts as a guideto assist engagement between the first arm members and the secondopposing arm members.

The respective rib members can be expanded or contracted eitherinternally or externally of the nasal cavity by urging the teeth againstthe recess until an adjacent trough engages the recess. The armcontaining the recess is sufficiently resilient to enable teeth membersto deflect the arm downwards as the teeth act against the recess.

The rib members can include an enlarged surface area that makes contactwith nasal cavity walls. This improves comfort of a wearer given that alarger surface area is in contact with surfaces of the nasal cavitywalls.

The first and second deformable bodies can include symmetrical enlargedportions that are convergent to make contact with internal surfaces ofthe nasal cavity. The lowermost portion of the U-shaped body can includeoppositely disposed contact members adapted to help retain the device inthe nasal cavity by contacting lower portions of the nasal cavity.

In a further embodiment of the present invention there is disclosed anasal cavity dilation device for improving flow of air through a nasalcavity including:

an elongate U-shape body having an uppermost and lowermost portion, thelowermost portion being sufficiently wide to span a nasal septum;

a pair of oppositely disposed adjustable rib members interconnected tothe uppermost portion of the body by an arcuate portion, the each ribmember extending downwardly at an angle to the body which angle isindependently adjustable by application of a force thereto; and

an adjustable holding means for each rib member including a system ofinterlocking components on the body and the wing member, theinterlocking components being adjustably interlockable to allow holdingand re-positioning of each rib member independent of the other to allowoptimization of air flow through the nasal passage of air therethrough.

The arcuate section(s) connecting the rib members to the body can be aliving hinge.

In a further related aspect of the present invention there is discloseda method of improving passage of air through a nasal cavity includingproviding a variable geometry device shaped for insertion within thenasal cavity; inserting the device within the nasal cavity and adjustingthe device to a desired geometry effective to apply a dilating force oninternal surfaces of the nasal cavity walls for improving passage ofair/fluid therethrough and adjustably retaining the device in thedesired geometry.

In a further embodiment of the present invention there is disclosed anasal dilation device for improving air flow through a nasal cavityincluding: a first deformable body and an adjustment member;

the first deformable body having an uppermost substantially circularopen end forming a collar and a lowermost substantially circular openend forming a waistband; a series of spaced ribs connecting between theuppermost and lowermost ends, the body including a central membermounted on the collar and extending longitudinally within the bodytowards the lowermost end;

the adjustment member being a closing compression member having aholding base and a central leg mounted thereon, which leg is able toextend into the first deformable body with the holding base engaging thewaistband of the first deformable body; the leg of the holding base andthe central member of the first deformable body having complementaryengagement means allowing engagement which causes the holding base toact against the waistband in response to an external force so that theribs are deflected outwardly of the body to a desired size for dilatingthe nasal cavity.

The central member of the first deformable body can be hollow and theleg of the holding base can include a series of spaced apartcircumferential protrusions of external diameter equal to or greaterthan the internal diameter of the hollow central member.

The ribs are generally extendable in a direction outwardly relative tothe body as the leg of the compression member progressively enters thehollow member so that the extent of desired dilation of a nasal cavitycan be controlled. The holding base can include a central platform onwhich the leg is mounted and extends upwardly towards the centralmember. The holding base can further include a locking ringinterconnected to the platform by a series of radial arms, the lockingring including an annular shoulder that abuts the waistband when the legengages within the central member. The holding base can also include arecessed protrusion for receiving a vapor delivery system. The nasaldilation device can include a second deformable body interconnected tothe first deformable body by a bridge, the first and second deformablebodies being substantially symmetrical about a longitudinal axisextending centrally of the bridge.

The novel features that are considered characteristic of the inventionare set forth with particularity in the appended claims. The inventionitself, however, both as to its structure and its operation togetherwith the additional object and advantages thereof will best beunderstood from the following description of the preferred embodiment ofthe present invention when read in conjunction with the accompanyingdrawings. Unless specifically noted, it is intended that the words andphrases in the specification and claims be given the ordinary andaccustomed meaning to those of ordinary skill in the applicable art orarts. If any other meaning is intended, the specification willspecifically state that a special meaning is being applied to a word orphrase. Likewise, the use of the words “function” or “means” in theDescription of Preferred Embodiments is not intended to indicate adesire to invoke the special provision of 35 U.S.C. §112, paragraph 6 todefine the invention. To the contrary, if the provisions of 35 U.S.C.§112, paragraph 6, are sought to be invoked to define the invention(s),the claims will specifically state the phrases “means for” or “step for”and a function, without also reciting in such phrases any structure,material, or act in support of the function. Even when the claims recitea “means for” or “step for” performing a function, if they also reciteany structure, material or acts in support of that means of step, thenthe intention is not to invoke the provisions of 35 U.S.C. §112,paragraph 6. Moreover, even if the provisions of 35 U.S.C. §112,paragraph 6, are invoked to define the inventions, it is intended thatthe inventions not be limited only to the specific structure, materialor acts that are described in the preferred embodiments, but inaddition, include any and all structures, materials or acts that performthe claimed function, along with any and all known or later-developedequivalent structures, materials or acts for performing the claimedfunction.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the invention is more readily understood embodiments willbe described by way of illustration only with reference to the drawingswherein:

FIG. 1 is a top perspective view of a fully assembled device inaccordance with a first embodiment of the invention.

FIG. 2 is a bottom perspective illustration of the embodiment in FIG. 1.

FIG. 3 is an exploded perspective illustration of the device of FIG. 1.

FIG. 4 is a top perspective view of a fully assembled device inaccordance with a second embodiment of the invention.

FIG. 5 is a bottom perspective illustration of the embodiment in FIG. 4.

FIG. 6 is an exploded perspective illustration of the device of FIG. 4.

FIG. 7 is a top perspective view of a fully assembled device inaccordance with a third embodiment of the invention.

FIG. 8 is a bottom perspective illustration of the embodiment in FIG. 7.

FIG. 9 is an exploded perspective illustration of the device of FIG. 7.

FIG. 10 is a top perspective view of a fully assembled device inaccordance with a fourth embodiment of the invention.

FIG. 11 is a bottom perspective illustration of the embodiment in FIG.10.

FIG. 12 is an exploded perspective illustration of the device of FIG.10.

FIG. 13 is a front diagrammatic view of a fully assembled device inaccordance with a fifth embodiment of the invention.

FIG. 14 is a front diagrammatic view of a fully assembled device inaccordance with a sixth embodiment of the invention.

FIG. 15 is a front diagrammatic view of a fully assembled device inaccordance with a seventh embodiment of the invention.

FIG. 16 is a front diagrammatic view of a fully assembled device inaccordance with a eighth embodiment of the invention.

FIGS. 17A, B, C, D, E, F, G&H are varying perspective views of a devicein accordance with a ninth embodiment of the invention with FIGS. 17A,B, C, D, E, F, & G being in a first undilated form and FIG. 17H being ina second dilated form.

FIGS. 18A & B, are varying perspective views of a device in accordancewith a tenth embodiment of the invention with FIG. 18A being in a firstundilated form and FIG. 18B being in a second dilated form.

FIGS. 19A, B & C, are varying perspective views of a device inaccordance with the invention in undilated form and dilated condition.

FIG. 20A is a device in accordance with the invention showing analternative holding and expanding mechanism.

FIGS. 21A, B & C illustrate a device according to the invention with aalternative holding mechanism.

FIGS. 22A B & C are varying perspective views of a device in accordancewith a tenth embodiment of the invention illustrating a device in anopen condition.

FIG. 23 is an end plan view of the embodiment shown in FIG. 22 in anopen condition.

FIG. 24 are varying perspective views of a device, in accordance with atenth embodiment of the invention, in assembled condition.

FIGS. 25A & B are end views of the device shown in FIG. 24.

FIGS. 26A & B are magnified perspective views of locking meansexemplified in the tenth embodiment.

FIG. 27 is a perspective view of a further embodiment in accordance withthe present invention.

FIG. 28 a, b and c represent the embodiment referred to in FIG. 27 in afront elevation, a plan view from beneath, and a plan view from aboverespectively.

FIG. 29 is a perspective view of an alternative embodiment of theinvention in partially assembled condition.

FIG. 30 a, b and c represents the embodiment referred to in FIG. 29 byway of a front elevation, a plan view from above, and a plan view frombeneath respectively.

FIGS. 31 a, b, and c illustrate a further embodiment of the presentinvention in perspective, in part cross-section, and schematicrespectively.

FIG. 32 is a perspective view of a fully assembled device and seconddevice in a disassembled form in accordance with a first embodiment ofthe invention.

FIG. 33 is a perspective view of a body component of the device in FIG.32.

FIG. 34 is a perspective view of an expansion means of the device ofFIG. 32.

FIG. 35 is a perspective view of a bridge member in accordance with asecond embodiment of the invention.

FIG. 36 is a perspective view of two devices joined by a bridging member

FIG. 37 is a perspective view of a fragrance/medicament holder accordingto the invention;

FIG. 38 is a perspective view of a demountable filter holder inaccordance with a preferred embodiment of the invention;

FIG. 39 is a perspective view of a fragrance/medicament holder accordingto FIG. 37 including a medicament pellet.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT WITH REFERENCE TO THEDRAWINGS

Referring to FIGS. 1 to 5 there is shown an improved adjustable nasaldilator device (1) insertable within the nasal cavity of a human beingto improve the flow of air through the nasal passage. The deviceincludes a body (2) comprising a top (3) and bottom (4) frame endsinterconnected by a series of spaced flexible ribs (5). The top andbottom frame ends are open and substantially circular, and the diameterof the bottom frame end is greater than the corresponding diameter ofthe top frame end to provide a body shape for convenient insertionwithin a nasal cavity.

The device (1) also includes a holding base member (6). As best seen inFIG. 2, the holding base member mounts the bottom frame end (4) of thebody (2). The holding base member includes an inner circumferentialplatform (7) for supporting the bottom frame end (4) of the body (2) ina mounting position. The holding base member also includes an outerconcentric circumferential platform (8) for mounting outer sheath (9).

The holding base member includes a series of mounting points (10)located in spaced relation on inner circumferential portions of theinner platform (7). The holding base member includes leg members (11)extending upwardly from the mounting points. The legs end in shoulderportions (12), which connect to a central platform (13). The legs andcentral platform form an internal housing structure for receivingcorresponding medicament housing (14) of medicament cartridge (15).

The device further includes an interlocking system consisting ofinterlocking components (16), mounted to the holding base member, andmating component (17) extending inwardly of the body (2) from the topframe (3). In operation the interlockable components maintain the top(3) and bottom frame (4) ends of the body at a distance effective forthe flexible ribs (5) to exert a desired dilating force for improvingpassage of air through the nasal cavity.

In the embodiment shown in the figures the releasable interlocking meansinclude:

an upstanding member extending from the central platform wherein whenthe holding base member is mounted on the bottom frame the upstandingmember is centrally located of the body, and wherein at least a part ofthe upstanding member includes a series of circumferential teeth;

a tubular sleeve member extending downwardly from the top frame end forreceiving the upstanding member, at least a part of the sleeve includingcomplementary internal teeth adapted to engage with the circumferentialteeth; and

wherein the upstanding member is received within the sleeve member uponapplication of an external force to one or both of the frame ends andthereafter the top and bottom frame ends are maintained at a desireddistance and allowing suitable lateral deformation of the flexible ribsto exert an effective force on surfaces of the nasal cavity walls toimprove passage of air therethrough.

The holding base member further includes a locking segment (14) forreceiving a medicament cartridge (14) in a releasable lockingengagement.

The nasal cavity dilation device is for urging the cavity towards anopen/dilated condition. The device has a body (8) with a flexible wallstructure formed by a plurality of longitudinally extending elongatedribs (32) extending between a top frame (31) and a bottom frame (33).The top frame (31) has an outer circular collar (35) with inner radiallike struts (36) providing flow through openings (37) and a shapedopening forming a mounting opening (38). The bottom frame (33) is acircular waistband with a plurality of elongated spaced ribs (32)connected to the collar (35) and the waist band (33). The ribs at leastare made from flexible plastics so that the wall structure has variablegeometry. The sizing of the device is such that it is insertable withinthe nasal cavity.

The nasal dilation device (5) further includes a compression meanscomprising a connecting link (41) having a stop (42) larger in dimensionthan the smooth elongated chord (43) and able to be held in the mountingopening (38). The smooth elongated chord extends in position through thecentre of the body (8). At or close to the top of the link (41) betweenthe stop (42) and the smooth elongated chord (43) is a plurality ofprotuberances (44). In this embodiment the protuberances are spacedsawtooth structure in profile. The plurality of protuberances (44)provide a plurality of locking positions when the smooth elongated chord(43) is pulled forcing the top frame (31) closer to the bottom frame(33) and thereby deflect the elongated ribs such that the geometry ofthe device is adjusted by application of a force on the compressionmeans (41) to cause the flexible wall structure to proceed from a firstsubstantially undilated geometry to adopt a second dilated geometry(best seen in FIGS. 17H and 18B).

A holding means in the form of a holding base (51) having a bottomlocking ring (52) and radial arm members (55) extending inwardly fromthe locking ring in a frustoconical configuration to a central platform(54) having a central shaped locking opening (58). The holding base (51)is sized to close off the bottom opening (39) of the body (8) of thedevice (5) by the locking ring (52) engaging the waistband (33) of thebody (8). The shaped locking opening (58) is able to receive aprotrusion (44) of the link (41) and thereby maintain the relativepositions of the top frame (31) and the bottom frame (33) and therebymaintain the flexible wall structure (32) in a selected second dilatedgeometry. In the second dilating geometry the device is sized andpositionable against and between the internal walls of the cavity andthe septum thereby opening the cavity to enable passage of air and/orfluid therethrough.

The device further includes a frustoconical filter (62) with a centralopening which is insertable in the central opening (53) of the lockingring (52) of the holding base (51). The filter (62) is held in positionby a closing frame (64) similar in structure to the holding base (51)but having a central circular opening rather than a shaped lockingopening (58).

It can be seen therefore that due to the frame work structure of thedevice and in particular the frame work structure of the top frame (31)the holding base (51) and the closing frame (64) and due to the porosityof the filter (62) airflow is available into the nasal cavity. Thevariable geometry of the wall structure including the ribs (32) isimplemented by a compression means engaging with the flexible wallstructure wherein the geometry of the device is adjustable byapplication of a force on the compression means to cause the flexiblewall structure to proceed from a first substantially undilated geometryto adopt a second dilated geometry.

The filter (62) can be a material such as felt which can in turn be usedto deliver medicated vapour such as that derived from “vapour rub”™.Alternatively a filtration device can be inserted within the closingframe to prevent inhalation of dust or pollens which can otherwiseinitiate allergic reaction by a wearer of the device.

FIGS. 4 to 9 show a nasal cavity device similar to the embodiment ofFIGS. 1, 2 and 3 except that instead of having a body 8 that issubstantially cylindrical, the body is pyramidal from a circular base toa top point. Another difference is the shape of the protuberances 44 onthe link and thereby the change of shape of the shaped locking opening(58). However the operation is substantially identical.

In FIGS. 10 to 12 the link is formed by a screw means (300) extendingthrough and being held by an opening in the top frame and engaging anelongated nut means (301) able to receive the screw and held by anexternal flange in the bottom frame. By relative twisting of the screwmeans and the elongated nut the top frame is brought towards the bottomframe and the flexible ribs can be deflected outwards to form a largerdilated second geometry of the required size for the nasal cavity of theuser.

In FIGS. 13 to 16 the body structure is substantially spherical with thelink (41) being formed of a sawtooth locking means in FIG. 13, a wiremeans in FIG. 14 that retains its position when the North and Southpoles of the body of the device are compressed towards each other. InFIG. 16 a plurality of circular protuberances (44) on the link areresistively engageable with an opening at the South pole of thespherical body shape.

FIGS. 17A, B, C, D, E, F, G&H are varying perspective views of a devicein accordance with a further embodiment similar to the initialembodiments. However they are shown in linked pairs for use in eachnostril of the user with each link being joined by a joining member(200). In this embodiment of the invention FIGS. 17A, B, C, D, E, F, & Gshow the device in a first undilated form and FIG. 17H is in a seconddilated form. With particular reference to FIGS. 17C and D there isshown the waistband (33) of the device exhibiting an angledconfiguration. An advantage of the angled waistband is that some nosesexhibit a lower septum relative to the internal wall of an adjacentnostril cavity so that a corresponding angled end frame on the deviceallows the device to be less obtrusive.

FIG. 17C, in a perspective view, also shows an alternative holding meansand compression means. In this embodiment the compression meanscomprises a connecting link (41) that is anchored at one end to the topframe (31) and includes an elongate chord. The chord exhibits a seriesof spaced apart protuberances (82) along a substantial portion of itslength. The holding means comprises a resilient boss or clip (80)integral to and extending from an internal surface of the waistband(33), having an opening (81) to hold the chord. The clip is sufficientlysmall and resilient to enable a protuberance or even a neck portion (84)of the chord, spaced between adjacent protuberances, to enter to extendin to the opening and thereafter being held captive within the clip tomaintain the elongate ribs in a desired condition. Alternatively theopening in the clip is only large enough to accommodate a length ofchord between the protuberances, and once a length of chord is placedwithin the opening, a protuberance, being larger than the opening, restsbeneath the opening to prevent the chord from being inadvertentlydisplaced.

In an alternative embodiment (not shown) the waistband can incorporatean opening therein which serves as a holding means. In this embodimentthe chord is able to be wedged tightly within the opening in thewaistband and thus the chord needn't include any protuberances.

FIGS. 18A & B also show a before use and in use position. FIG. 18Arepresents a first undilated form showing a substantially cylindricalbody shape while FIG. 18B is in a second dilated form in a substantiallyspherical shape.

Referring to FIG. 18B there is shown a fully assembled device locked ina compressed condition. During the operation of compression, the ribwalls (32) move outwardly from the resting geometry of the device todescribe an altered geometry akin to a continuous parabolic-shapedcurve. In this altered geometry at least a part of the surface area of arib wall (32) makes contact with the internal surface of the cavity. Therib walls (32) are fabricated from resilient materials such as plastics,which enable them to exert and maintain an opening pressure on theinternal surface of the cavity.

Referring to FIGS. 19A, B & C there is shown a device linked in tandemfor insertion within nasal cavities one device being joined to the otherby a link (93). As is shown the tandem device can include acircumferential ring (95) mountable within the opening defined by thewaistband. The ring can include a material such as a felt thereon forretaining a substance capable of delivering a vapour. Alternatively thecircumferential ring can include a filter (96) which can be of a desiredpore size to reduce inhalation of airborne particulate matter that canotherwise initiate an allergic reaction.

FIG. 20 shows a tandem device having an alternative compression andholding mechanism. While the principal of operation is similar to thatillustrated in FIG. 12 the differences of note are that the elongatelink (41) is fixed to the top frame (31) and includes a series of spacedapart protuberances (92) along a substantial part of its length. Thelink is held in a desired position by a holding means in the form of aholding base (51) with a centrally located upstanding base (175)supported by base cross-members (176). The upstanding base has acentrally located bore (177) with internal mating threads extendingalong one side of the bore for mating with the protuberances (92) on thelink (41). In order to compress the adjustable ribs (32) an externalpressure is applied to either the top and/or bottom frame thereby tourge the protuberances within the bore and into mating engagement withthe portion of the bore that includes internal threads. To release thedevice from an expanded condition the bottom frame is rotated so thatthe protuberances disengage from the internal threads on the one side ofthe bore and thereafter the protuberances can freely slide to releasethe link from the bore. The devices are linked together by a nose bridge(103) which includes a recess for housing a vapour dispenser (104).

Referring to FIGS. 21A, B, and C there is shown a modification to FIG.20 wherein one part of the holding means is a clip (277) positioned onan internal surface of the waistband (33) for receiving a correspondingprotuberance (44) on the link (41). FIG. 21B shows the device in acompressed/expanded condition and a non-expanded condition. In bothinstances the chord is held in a position by locking a protuberancewithin the clip.

As shown in FIGS. 4, 5 and 6 the device has a resting-geometry in theabsence of compression, for enabling easy insertion within a bodycavity, although it is understood that the device can be dilated priorto insertion within a nasal cavity. The resting geometry of thestructure (4) exhibits a bullet or dome type shape wherein the collar(6) exhibits a smaller relative circumference to the opposite waistbandend (7) to facilitate easy insertion of the device within a cavity. Inthe resting geometry the device (5) is sufficiently small to enableinsertion within a very wide range of cavity sizes and thereafter thegeometry changes as a force is exerted on the top end of the structureby the chord (41) to urge a surface of the ribs against the nasal cavityto improve breathing and air flow within the cavity.

The applicant does not intend to limit the invention to the disclosedembodiments, and any modifications or alterations that are obvious to aperson skilled in the art from this disclosure are within the scope ofthis invention and covered herein.

Referring to FIGS. 22A, B and C there is shown a device (500) accordingto a tenth embodiment of the present invention for insertion within anasal cavity. The device (500) is a unitary device which can bemanufactured in a single step injection moulding process. The deviceincludes a bridge (501) and two upstanding support members (502)extending substantially at right angles to the bridge and exhibitingsymmetry about an axis defined by point A-A to form a rigid bodystructure. The upstanding support members (502) end in shoulders (503).The shoulders (503) generally exhibit an inverted U-shape structureextending from the body distal to the bridge, terminating in an enlargedend (504) which surface area rests flat against internal walls of anasal cavity without causing discomforture of a user. The shoulders(503) include a first and second curved segment (505) and (506)respectively, separated by a living hinge (507) to enable the secondsegment (506) of the shoulder to pivot relative to the first segment(505).

The device (500) further includes a radial arm member (508) attached toand extending from the upstanding support members (502) at an acuteangle by a living hinge. The arms (508) are able to move in a verticalplane in alignment with the upstanding support member(s), to describe anarcuate pathway. The arms (508) are biased laterally so that the arm, ifmoved away from the vertical plane defined by the upstanding supportmember, will be urged back towards its original position.

The arm member(s) (508) end in a circumferential ring (509) havingoppositely facing surfaces (513 and 522) surrounding an opening (512).On one surface (513) of the ring (509) there is a series of teeth (510)being interlockable with corresponding mating teeth on a second armmember (511). The second arm member (511) extends from a surfaceadjacent the enlarged surface area (504) and is angled oppositely to thefirst arm member (508). The second arm member is joined at a surfacenear the enlarged surface area (504) by a living hinge which enables thesecond arm to pivot up and down in a substantially vertical plane. Thesecond arm (511) ends in a protuberance (514) which includes an innercylindrical core (515) with an outer core (516) encircling at least apart of the external wall of the inner core. The outer core has a firstand second opposing face (517, 518) having teeth moulded onto the firstface (517) for engagement with corresponding teeth (510) on the armmember (508).

The second arm (511) also includes a flange element (519) extendingupwardly from the inner core (515). The flange (519) incorporates a neck(520) which passes through opening (512) in the circular protuberance(509) in an engaged condition, ending in a shoulder (521) that engages asurface (522) of the circumferential ring (509).

In an operating condition the device (500) requires arm member(s) (508)and (511) to be forced apart laterally against the natural bias so as toallow engagement of mating teeth on respective surfaces ofcircumferential ring (509) and protuberance (514). Prior to engagementof mating teeth the flange element (519) is passed through the opening(512) until the shoulder (521) of the flange rests against surface (522)of the circumferential ring. Once in an engaged condition the device(500) can be inserted within a users nasal cavity so that the bridge(501) spans the septum of a nose and the upstanding support members(502) bear against internal cavity walls. Once in an inserted conditiona force can be applied against the engaged circumferential portions ofthe arms thereby to cause hinged movement of the arms relative to thesupport members. As the arms are displaced the interlocking teeth areurged over each other to allow corresponding outward displacement of theshoulder (506) about hinge (507). In this condition the enlarged area(504) of the arm exerts an opening pressure on the nasal wall to expandthe nasal cavity.

In this embodiment the device can be retained in the nasal cavity in asuitably expanded state without inadvertent removal. The arms can bemaintained in a relative position by the mating locking teeth. Theshoulder portion (506) can be hingedly displaced outwardly by exerting aforce against the interlocked ring (502) and protuberance (514) so as toenable the enlarged end to exert a desired pressure against the nasalwall. As a force is applied to the locked members the mating teethdisengage to enable hinged movement of the arms. When the nostril cavityis expanded sufficiently the teeth can be interlocked to retain the armsin the new/expanded condition. When the arms (508) and (511) arehingedly displaced in relation to the applied force, the shoulderportion (506) is correspondingly displaced outwardly about the livinghinge (507) to enable the enlarged surface area (504) of the shoulder toexert a positive pressure against the internal walls of a nasal cavity.

In this embodiment the device can be adjusted manually insitu to openthe nasal cavity. The upstanding support members of the device braceagainst one side of a nasal cavity while the shoulder portion (506) ispivotable about hinge (507) in concert with hinged movement of armmembers (508) and (511) on application of an external force. The bridge(501) prevents the device from being inadvertently inhaled by a user andacts as a rigid support for bracing a surface of the nasal cavity wall.When the device adopts an expanded condition the enlarged end and theupright member(s) brace against the walls of the cavity and effectivelyprevent inadvertent removal of the device from the cavity.

Referring to FIG. 27 there is shown a modification of the deviceillustrated in FIGS. 22A, B and C. The modified nasal dilation device(1000) is preferably moulded in a single step process and includes agenerally U-shaped body (1001) having an uppermost part (1002) and alowermost part (1003) interconnected by a pair of spaced resilientupright members (1004). The modified device (1000) is symmetrical aboutaxis A-A, best seen in FIG. 28 a, hence for convenience an explanationis provided for one half of the device which will in turn apply for theequivalent opposite symmetrical feature.

The uppermost part of the U-shaped body extends outwardly at an angle tothe upright member (1004) via a curved section (1005) to form aresilient rib or wing member (1006). The wing member (1006) includes aflattened section (1007) which in an operating condition rests againstinternal wall surfaces of a nasal cavity. The flattening and broadeningof the wing section serves to increase the surface area in contact withinternal cavity walls to spread the concentration of force exerted bythe device over a wider surface as practicable.

The wing member (1006) includes an inwardly extending arm (1008) whichhas a series of resiliently spaced teeth (1009) separated by troughs(1014). The upright members (1004) of the body (1001) include twointegrally formed and spaced apart arms (1010 and 1011) which extendoutwardly towards the extending arm (1008) the spaced apart arms (1010and 1011) being capable of engaging with the extending arm (1008) in anoperating condition. Arm member (1011) includes a pair of downwardlyextending flanges (1012) spaced apart to both receive and align armmember (1008) therebetween. Arm member (1010) includes a u-shaped recess(1013) adjacent its end for receiving troughs (1014). When troughs(1014) are engaged within the recess (1013), adjacent teeth (1009) reston either side of the recess (1013) to maintain the wing member (1006)in a locked position at a constant angle to the body (1001).

Arm members (1010 and 1011) are resiliently formed relative to theupright members (1004) so that, when a force is applied to the wingmembers (1006) in the direction indicated by arrows (x), teeth members(1009) cause downward deflection of the arm (1010) as a tooth acts on asurface of the recess until an adjacent trough (1014) is engaged withinthe recess (1012). In this way adjustment of the angle between the wingmember and the body can occur in a reversible manner. For example,referring to FIG. 28 a, there is illustrated a modified device in afully expanded condition. If it is desired to reduce the angle betweenthe wing member and the body, a user/wearer is able to attend toadjustment by applying an external force against flattened sections(1007) of the wing member in the direction of (X).

In an insertion condition a trough closest to the wing member (1006) isengaged within the recess (1012) so that the angle between the wing andthe body is reduced. Once inserted in a nasal cavity a user can apply anoutwardly directed force on a lower inner surface of the wing member.Once the wing member is expanded sufficiently to promote increasedairflow, the angle between the wing and the body is sustained by firmengagement of a trough between adjacent teeth within the recess.

In use the lowermost portion (1003) of the body is seated outside thenasal septum and upright members (1004) include a flat section (1020)which abuts internal wall structure of a nasal cavity. Generally atleast the lower most portion of the body is transparent or fleshcoloured so as to render the device inconspicuous from a casualobserver.

Referring to FIGS. 29 and 30 a, b and c there is shown a modification ofthe cage dilation system (2000) embodied in FIG. 20. The cage dilationsystem (2000) illustrated in FIGS. 29 to 30 a, b and c is divided intotwo body parts (2001) interconnected by a U-shaped bridge (2002). Thetwo body parts exhibit symmetry about vertical axis XX′, hence forconvenience where reference is made to one body an identical componentis present on the second body part. The body part (2001) includes anuppermost part (2003) forming a collar (2004) and a lowermost part(2005) forming a waistband (2006). The collar and waistband areintegrally interconnected by a series of spaced flexible ribs (2007)which flex outwardly from the body describing an arcurate pathway (notshown) when an external compressive force is applied against theuppermost and lower most ends.

The collar (2004) includes an integrally formed hollow cylindricalmember (2008) located centrally and extending inwardly of the body.

The cage dilation system according to FIGS. 29 and 30 a, b and c furtherincludes a holding means (2000) (best seen in FIG. 29). The holdingmeans comprises:

a hollow cylindrical member (2008), formed integrally of the collar(2004), and located centrally and extending inwardly of the body; and

a shaft (2010) extending upwardly and centrally from a holding base(2011).

The holding base includes a locking ring (2017) which has an annularshoulder (2012) that abuts the rim (2013) of the waistband when theshaft (2010) is engaged within the hollow cylinder (2008).

The holding base (2011) has a central platform (2015) from which theshaft (2010) extends upwardly to be received within the hollow cylinder(2008). The holding base also includes integral radial arm members(2016) interconnecting the central platform (2015) to the locking ringmember (2017). The central platform (2015) includes a protrusion (2018)extending beneath the level of the locking ring. The protrusion (2018)has a recess (2019) (best seen in FIG. 30 a) on which a vapour deliverysystem can be mounted (not shown).

The shaft (2010) has a series of spaced protrusions (2014) along itslength which positively engage the internal surface of the hollowcylinder in an operating condition. It is generally understood that theinternal diameter of the hollow cylinder is less than the externaldiameter of the protrusions so as to enable the protrusions to bothdeflect and positively engage the hollow cylinder as it moves throughthe cylinder.

In an operating condition (seen in FIG. 30 a) the shaft (2010) isdisplaced through the opening of the hollow cylinder by applying anexternal force between the locking ring on the holding base and thecollar (2004). Generally the cage system is fabricated from a resilientplastic material so that when the shaft enters the opening in the hollowcylinder the protrusions (2014) act against the internal surfaces of thehollow cylinder, thereby deflecting the internal surfaces to enabledisplacement and enabling positive engagement therewith. As the shaft isdisplaced along the hollow cylinder the flexible ribs (2007) extendoutwardly to describe an arcurate pathway. In use the ribs rest againstinternal wall surfaces of a user's nasal cavity. When the ribs areextended by applying a compressive force between the collar and thewaistband, the walls of the nasal cavity against which the ribs are atrest, extend in response to the outward expansion of the ribs to promoteflow of air through the cavity.

Referring to FIG. 31 a, b, and c there is shown a further embodiment ofthe device of the present invention. The device has a body (5008) with aflexible wall structure formed by a plurality of longitudinallyextending elongated ribs (5032) extending between a top frame (5031) anda bottom frame (5033). From the top frame (5031) a longitudinal tubularsleeve member (5001) extends centrally of the body. The tubular sleevemember is formed by the each rib member folding inwardly of the bodyfrom the top frame end in an inverted U-shape cross-section, withwebbing (5003) interspersed between each fold (5004). The bottom frame(5033) is a circular waistband which has a greater diameter than the topframe end so that the sizing of the device is such that it is insertablewithin the nasal cavity.

The cage dilation system (5000) illustrated in FIGS. 31 a, b and c isdivided into two body parts interconnected by a U-shaped bridge (5005).The two body parts exhibit symmetry about vertical axis XX′, hence forconvenience where reference is made to one body an identical componentis present on the second body part.

The device includes a holding base (5006) received within the waistband.The holding base includes a central platform connected thereto by radialcomponents and a central member (5007) mounted on the platform extendingupwardly therefrom and centrally of the body. The device also includes aholding means comprising oppositely disposed interlocking components.The interlocking components comprise the tubular sleeve member (5001)and opposing central member, wherein at least a part of the tubularsleeve and the central member include complementary mating means so thatwhen a force is applied to one or both of the top or bottom frame endsthe central member is received within the tubular sleeve and is held ina desired position. In this embodiment the tubular sleeve includes aseries of teeth (5008) and the central member includes a series ofmating teeth (5015) which interlock. In use when a force is applied toone or both of the top or bottom frame ends the rib members expandlaterally. When a suitable size is obtained to sufficiently enlarge thenasal passage, the holding means maintain the size of the device untilreleased. To aid comfort of a wearer, the rib members are shaped toinclude an enlarged mid-section thus optimizing the surface area of theribs in contact with a surface of the nasal cavity wall.

In a further embodiment illustrated with reference to FIGS. 32 to 36,there is shown a nasal cavity device (6000) for combined flow of airthrough the nasal passage and a medicament or fragrance. The deviceincludes a body (6001) shaped for insertion within a human nasal cavity.The body has a top frame end (6002) and a bottom frame end (6003)interconnected by a series of spaced apart ribs (6004). The body is madefrom a plastic material and the ribs structurally deform laterally (notshown) to exert a force on internal surfaces of a nasal cavity effectiveto improve airflow through the nasal passage of a wearer.

The device includes an expansion means (6005), which mounts the bottomframe end (6003) of the body. The expansion means comprises a base ringstructure (6006) having an inner circumferential shoulder (6020) onwhich the bottom frame end is seated in an operating condition. Theexpansion means when mounted to the body defines a first airflow pathwaywithin the device. The expansion means also includes a central housingstructure (6021) comprising interrupted wall members such as a series ofspaced apart legs (6009) interconnected to a centrally located platform(6022) wherein the legs extend substantially upwardly within the bodyfrom or adjacent to edge portions of the inner circumferential shoulder.

In this embodiment one end of the spaced legs end in shoulder portions(6023) which each connect directly to the central platform (6022). Theother end of the spaced legs is mounted to the base ring structure byfeet 6050. The feet include an opening (6060) to receive engagingportions (6051) of a bridge (6025).

As best seen in FIGS. 335 and 34, the device further includes areleasable locking system for releasably locking the expansion means andthe body in operable engagement. The locking system consists of male andfemale interlocking components (6007) and (6008). Male component (6007)is mounted centrally of the expansion means by the interrupted wallmembers (6009). The female mating component (6008) extends centrally andinwardly of the body from the top frame end.

In an assembled condition (best seen in FIG. 32), the male and femaleinterlockable components engage and thereby urge the expansion meansagainst the bottom frame end. In a progressively engaged condition thetop frame end and bottom frame end of the body are adjustably maintainedat a desired distance effective for the flexible ribs to deformlaterally to exert a desired dilating force on nasal for improvingpassage of air through the nasal cavity.

As can be seen the male component (6007) is elongate and includes aleading end (6010) and a threaded section (6011). The female component(6008) is located centrally of the body and is generally cylindrical andtapered between the top frame end and opening (6012). The leading end(6010) is generally larger than the opening (6012) and is adapted to bereceived within the opening of the female component and thereafter thethreaded section frictionally engages inner sidewall portions of thefemale component. The threaded section allows both rotational and lineardisplacement of the male component within the female component.

In operation, as the male component is advanced by rotational or linearmovement within the female component, a force is exerted against thebottom frame end by the expansion means causing rib members to deformlaterally of the body.

As seen in FIGS. 35 and 39, the device further includes a demountablefragrance/medicament holder (6013) adapted to be mounted in theinterrupted wall structure (6009) of the expansion means such that thefragrance holder and expansion means define a fragrance/medicamentchannel accessible to the first airflow pathway.

The fragrance holder includes a ring-like base structure beinginterconnected to a central holding structure (6015) having aninterrupted well structure (6016) and an annular mounting structure(6014) with airflow cavities therebetween to allow mounting whileallowing longitudinal ingress of airflow past the central holding means.In operation air flowing through the first airflow pathway passes intothe fragrance channel for fragrance dispensing whereby fragrance mergeswith the first airflow pathways within the device.

In an assembled condition the central holding structure (6015) of thefragrance holder is received within the central housing structure (6021)of the expansion means, wherein the platform (6022) rests on theinterrupted well structure (6016) thereby forming a roof for the centralholding structure (6015). The fragrance holder includes a u-shapedrecess (6026) within the ring-like base structure to accommodate an armportion (6052) of the bridge member (6025).

In this embodiment of the invention the male component (6007) is mountedto the roof and extends into the body, and the female element (6008) isan oppositely disposed tubular sleeve structure extending within thebody and wherein the male element is received in a releasable conditionwithin the female element to substantially maintain the ribs in adesired deformed position to exert an effective force on internalsurfaces of the nasal cavity walls.

The device as seen in FIG. 32 includes an outer sheath (6027) adapted tomount over the rib portion of the body. The sheath comprises acircumferential bottom frame end, which in use is supported on the outercircumferential platform of the expansion means, and spaced apart ribsextending upwardly from the circumferential bottom frame end ending incurved fingers (6028) for gripping attachment at the top frame end ofthe body.

As shown in FIGS. 32 and 36, the device can be joined to a second deviceby means of a bridge member (6025) whereby each device is adjustedindependently or cojointly. The bridge member includes a generallysymmetric u-shaped transparent structure (6029) ending in adjustableengaging portions (6051). The fragrance holder includes a recess (6026)in the base ring structure so that when the fragrance holder is mountedto the expansion means the recess accommodates a portion of the bridgemember.

In a further preferred embodiment of the invention shown in FIG. 38, thedevice includes a demountable filter holder (6032) having an annularstructure (6033) adapted to be mounted to a portion of the expansionmeans wherein the annular structure includes cavities to allow airflow.The mounting structure receives a filter member (6034) in a seatedarrangement adjacent the nasal cavity opening. Air entering the firstdefined airflow pathway passes through the filter member and lateraldeformation of the rib portion of the body is sufficient to exert aneffective opening force on the nasal cavity walls to substantiallyminimize resistance to airflow by the filter member.

The filter holder includes a circular base (6035) and annular mountportions (6033) adapted to engage receiving portions within theexpansion means. The filter holder further includes radial arms (6036)and a semi-circular recess (6037) for receiving at least a portion of abridging member. The filter member is a circular pad, the diameter ofwhich is sized to abut wall surfaces of the nasal cavity.

The preferred embodiment of the invention is described above in theDrawings and Description of Preferred Embodiments. While thesedescriptions directly describe the above embodiments, it is understoodthat those skilled in the art may conceive modifications and/orvariations to the specific embodiments shown and described herein. Anysuch modifications or variations that fall within the purview of thisdescription are intended to be included therein as well. Unlessspecifically noted, it is the intention of the inventor that the wordsand phrases in the specification and claims be given the ordinary andaccustomed meanings to those of ordinary skill in the applicable art(s).The foregoing description of a preferred embodiment and best mode of theinvention known to the applicant at the time of filing the applicationhas been presented and is intended for the purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise form disclosed, and many modifications andvariations are possible in the light of the above teachings. Theembodiment was chosen and described in order to best explain theprinciples of the invention and its practical application and to enableothers skilled in the art to best utilize the invention in variousembodiments and with various modifications as are suited to theparticular use contemplated.

What is claimed is:
 1. A nasal cavity dilator device for combined flowof air through the nasal passage and a medicament or fragrance and thelike, the device including: a body for insertion within a human nasalcavity, the body being capable of deforming to exert an effective forceon internal surfaces of a nasal cavity and thereby improve air flowthrough the nasal passage; an expansion means for mounting the body,wherein in an operating condition the expansion means urges against thebody causing the body to deform; at least one defined air flow pathwaywithin the device; a releasable locking means for locking the expansionmeans and the body in operable engagement; a demountablefragrance/medicament holder mounted in a portion of the expansion meanswherein the fragrance holder and expansion means define afragrance/medicament channel accessible to the air flow pathway; whereinair entering the fragrance channel dispenses fragrance or medicament orthe like from the fragrance/medicament holder into the air flow pathway.2. A nasal cavity device for combined flow of air through the nasalpassage and a medicament or fragrance according to claim 1 wherein thefragrance channel includes an air inlet and air outlet to allow air flowthrough the channel for fragrance dispensing whereby fragrance mergeswith the at least one defined air flow pathways within the device.
 3. Anasal cavity device for combined flow of air through the nasal passageand a medicament or fragrance according to claim 1 wherein the fragranceholder is mounted in a central portion of the expansion means tomaximize airflow and fragrance dispensing.
 4. A nasal cavity device forcombined flow of air through the nasal passage and a medicament orfragrance according to claim 3 wherein the fragrance holder includes acentral holding means with interrupted well structures to allow lateralegress of fragrance or medicament or the like and an annular mountingmeans with air cavities therebetween to allow mounting while allowinglongitudinal ingress of air flow past the central holding means.
 5. Anasal cavity device for combined flow of air through the nasal passageand a medicament or fragrance according to claim 1 wherein the expansionmeans includes a central housing structure comprising interrupted wallmembers ending in a centrally located platform, which extends into thebody of the device.
 6. A nasal cavity device for combined flow of airthrough the nasal passage and a medicament or fragrance according toclaim 1 wherein the releasable interlocking means includes a male andfemale mating elements.
 7. A nasal cavity device for combined flow ofair through the nasal passage and a medicament or fragrance according toclaim 6 wherein the male element is mounted to the roof and extends intothe body, and the female element is an oppositely disposed tubularsleeve structure extending within the body and wherein the male elementis releasably received within the female element to substantiallymaintain the body in a desired deformed position to exert an effectiveforce on internal surfaces of the nasal cavity walls.
 8. A nasal cavitydevice for combined flow of air through the nasal passage and amedicament or fragrance according to claim 1 wherein the body cancomprise a top frame end forming a collar and a bottom frame end forminga waistband wherein the top and bottom frame ends are interconnected bya deformable wall structure.
 9. A nasal cavity device for combined flowof air through the nasal passage and a medicament or fragrance accordingto claim 8 wherein the deformable wall structure is preferably formedfrom a series of spaced-apart rib members.
 10. A nasal cavity device forcombined flow of air through the nasal passage and a medicament orfragrance according to claim 1 wherein in an assembled condition theexpansion means is mounted on the bottom frame end, and wherein in anoperating condition the expansion means is urged by an external forceagainst the bottom frame end causing displacement of the bottom frameend towards the top frame end whereby the flexible wall structuredeforms laterally of the body to exert a force against internal surfacesof a nasal cavity wall.
 11. A nasal cavity device for combined flow ofair through the nasal passage and a medicament or fragrance according toclaim 1 wherein the releasable locking means includes: an upstandingmember extending from the central platform of the expansion means,wherein when the expansion means is mounted on the bottom frame end theupstanding member is centrally located of the body, and wherein at leasta part of the upstanding member includes a series of circumferentialteeth; a tubular sleeve member extending downwardly from the top frameend for receiving the upstanding member, at least a part of the sleeveincluding complementary internal teeth adapted to engage with thecircumferential teeth; and wherein the upstanding member is receivedwithin the sleeve member upon application of an external force to one orboth of the frame ends and thereafter the top and bottom frame ends aremaintained at a desired distance and allowing suitable lateraldeformation of the flexible ribs to exert an effective force on surfacesof the nasal cavity walls to improve passage of air therethrough.
 12. Anasal cavity device for combined flow of air through the nasal passageand a medicament or fragrance and the like, the device including: a bodyfor insertion within a human nasal cavity, the body being capable ofdeforming to exert an effective force on internal surfaces of a nasalcavity and thereby improve air flow through the nasal passage; anexpansion means for mounting the body, wherein in an operating conditionthe expansion means urges against the body causing the body to deform,the expansion means including a central housing structure comprisinginterrupted wall members ending in a centrally located platform whichextends into the body of the device; at least one defined air flowpathway within the device; a releasable locking means for locking theexpansion means and the body in operable engagement; a demountablefragrance/medicament holder including central holding means comprisinginterrupted well structures to allow lateral egress of fragrance ormedicament or the like and an annular mounting means with cavitiestherebetween to allow mounting to the expansion means while allowinglongitudinal ingress of air flow past the central holding means, whereinin an assembled condition the central holding means of the fragranceholder is received within the central housing structure such that theplatform rests on the interrupted well structures to form a roof for thecentral holding means thereby defining a fragrance or medicament channelfor merging with the air flow pathway.
 13. A nasal cavity device forcombined flow of air through the nasal passage and a medicament orfragrance according to claim 12 wherein the expansion means includes abase ring structure having an inner circumferential shoulder forsupporting the bottom frame end thereon and an outer concentriccircumferential platform for supporting an external sheath/cage forprotecting the body.
 14. A nasal cavity device for combined flow of airthrough the nasal passage and a medicament or fragrance according toclaim 13 wherein the expansion means includes a central housingcomprising interrupted wall members such as a series of spaced apartlegs interconnected to a central platform wherein the legs extendsubstantially upwardly within the body from or adjacent to edge portionsof the inner circumferential shoulder.
 15. A nasal cavity device forcombined flow of air through the nasal passage and a medicament orfragrance according to claim 14 wherein the spaced legs end in shoulderportions which each connect directly to the central platform.
 16. Anasal cavity device for combined flow of air through the nasal passageand a medicament or fragrance according to claim 14 wherein the edgeportions include an opening therein to receive portions of a bridgestructure.
 17. A nasal cavity device for combined flow of air throughthe nasal passage and a medicament or fragrance according to claim 12wherein the fragrance holder includes a ring-like base structure beinginterconnected to a centrally located housing structure wherein air flowcavities are located therebetween.
 18. A nasal cavity device forcombined flow of air through the nasal passage and a medicament orfragrance according to claim 17 wherein the centrally located housing iscomprised of spaced wall sections adapted to be received within thecentral housing of the expansion means.
 19. A nasal cavity device forcombined flow of air through the nasal passage and a medicament orfragrance according to claim 17 wherein the fragrance holder includes au-shaped recess within the ring-like base structure to accommodate anarm portion of a bridge member.
 20. A nasal cavity device for combinedflow of air through the nasal passage and a medicament or fragranceaccording to claim 12 wherein the releasable locking means is comprisedof interlocking components on the top frame end and the expansion means,the interlocking components being adjustably interlockable formaintaining the top and bottom frame ends of the body at a distanceeffective for the wall structure to exert a desired dilating force forimproving passage of air through the nasal cavity.